Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03468764
Other study ID # 1/int/2018
Secondary ID
Status Not yet recruiting
Phase
First received March 12, 2018
Last updated March 16, 2018
Start date March 2018
Est. completion date April 2019

Study information

Verified date March 2018
Source IRCCS San Raffaele
Contact Marco Gemma, MD
Phone +390226437863
Email gemma.marco@hsr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Intraoperative hemodynamic management is important, since even mild variations in circulatory volume can be extremely damaging for patients.

Minimally invasive hemodynamic monitoring are not always available or cost-effective, therefore management of fluids is challenging for anesthesiologists.

This study aims to assess if, after performance of a lung recruitment maneuver (LRM), standard parameter's variation differs between hypovolemic and normovolemic patients.

Patients' volemic state will be assessed with the Vigileo system. Standard monitoring values (heart rate, invasive blood pressure and saturation) will be registered before and after LRMs.

A fluid challenge will be performed and the above mentioned parameters will be recorded again, after a second LRM.

The study is a prospective observational study.


Description:

During general anesthesia, it's important to maintain normovolemia, since hypovolemia can cause inadequate tissue perfusion and hypervolemia increases the rate of complications, overall mortality and morbidity.

Critically ill patients commonly present with important hypotension that, in the majority of cases, is promptly treated with intravenous fluids to reverse organ hypoperfusion.

However, previous studies have demonstrated that only 50% of hemodynamically unstable patients are responsive to fluid administration.

In the last decade, attention has been focused on finding a parameter capable of assessing fluid responsiveness in a hypotensive patient.

Recent articles have demonstrated that standard monitoring parameters have no significance for this purpose, while hemodynamic parameters, like stroke volume variation (SVV) or pulse pressure variation (PVV) may have an important role.

An interesting field of research involves heart-lung interactions during mechanical ventilation. In particular, lung recruitment maneuver (LRM) induce physiological cardiovascular alterations and may have a correlation with the volemic state of the patient.

LRMs are commonly performed and safe procedures that consist in application of a continuous positive pressure in the lungs of mechanically ventilated patient, with the aim of improving pulmonary compliance.

The goal of our study is to verify whether the alterations induced by lung recruitment maneuver on commonly registered intraoperative parameters, such as heart rate and arterial blood pressure, actually differ when the maneuver is applied to hypovolemic and normovolemic patients respectively.

Patients undergoing scheduled laparoscopic colon surgery will be enrolled. Informed consent will be obtained during the preoperative anesthesiological visit.

General anaesthesia will be managed according to standard clinical practice. Invasive blood pressure monitoring will be started with a peripheral arterial catheter and hemodynamic parameters (SVV and CO) will be monitored through the Vigileo device.

During the resection phase, the patient has to be maintained in hypovolemic conditions. When SVV reaches a value of 12-15%, a LRM is performed, consisting in the application of 30 cm H2O continuous positive airway pressure for 30 seconds.

Standard monitoring values (heart rate, invasive blood pressure and saturation) will be registered.

Thereafter, a fluid challenge will be performed, consisting in intravenous administration of 8 ml/kg of saline solution over 20 minutes. As soon as SVV will reach a value of 10%, LRM will be performed again and the abovementioned three sets of measurements will be carried out once again.

As standard management of LRM, the maneuver will be stopped if the heart rate would lower below 35 bpm or the systolic blood pressure would lower below 60 mmHg.

The information provided by the study is of interest in cases in which the deployment of sophisticated monitoring, as the Vigileo system, is not feasible or cost-effective. In this way, hemodynamic management during major surgeries would become faster and easier, relying on traditional monitoring.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >18 years

- Elective surgery

- ASA score 1-2-3

- Informed consent

Exclusion Criteria:

- Pregnancy

- Relevant cardiac/pulmonary comorbidities

- Cardiac/kidney failure

- Haemodynamic shock

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Vigileo monitoring during lung recruitment maneuver
Standard monitoring parameters, invasive blood pressure and hemodynamic values (SVV and CO, through Vigileo device) will be monitored. With the patient in a supine position and as SVV reaches a value of 12-15%, a LRM is performed, consisting in the application of 30 cm H2O continuous positive airway pressure for 30 seconds. The alterations in the above mentioned parameters will be registered before and after the maneuver. The same procedure will be performed after a 8 ml/kg crystalloids fluid challenge, as soon as SVV reaches the value of 10%.

Locations

Country Name City State
Italy S. Raffaele Hospital Milano MI

Sponsors (1)

Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypovolemic indicator Finding an hypovolemic indicator among standard monitoring parameters Intraoperative
See also
  Status Clinical Trial Phase
Suspended NCT02315937 - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' N/A
Active, not recruiting NCT01681238 - Goal-directed Therapy in High-risk Surgery N/A
Completed NCT01210417 - Trauma Heart to Arm Time N/A
Recruiting NCT05557461 - Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?
Withdrawn NCT03246425 - Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study N/A
Completed NCT02721654 - Plasma-Lyte 148® versUs Saline Study Phase 4
Completed NCT02903316 - Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles N/A
Completed NCT03009305 - Cerebral Oximetry in Lower Body Negative Pressure N/A
Completed NCT01456559 - Detection of Hypovolemia Using Pleth Variability Index (PVI) N/A
Completed NCT00380107 - Volume Deficit Prior to Surgery Phase 4
Recruiting NCT06123039 - Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
Completed NCT04573842 - Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
Completed NCT05150418 - Supplemental Oxygen in Hypovolemia Phase 1
Completed NCT02961439 - Validation of Epworth Richmond's Echocardiography Education Focused Year N/A
Completed NCT01535703 - Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography N/A
Completed NCT01010022 - Trial of 6% HES130/0.4 Phase 3
Completed NCT04641949 - Methoxyflurane and Fentanyl in LBNP Phase 4
Recruiting NCT03592290 - Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
Suspended NCT03736421 - Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
Completed NCT02679625 - Comparison of Non-Invasive Methods of Assessing Fluid Responsiveness in ED and ICU Patients